MAUDE Adverse Event Report: BOSTON SCIENTIFIC NEUROMODULATION VERCISE GENUS; STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN SYMPTOMS

Model Number DB-1216

Device Problem Premature Discharge of Battery (1057)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 02/06/2024

Event Type  malfunction  

Event Description

It was reported that the deep brain stimulation (dbs) patient experienced rapid depletion of the implantable pulse generator (ipg) battery after undergoing a revision procedure (reported in mfr# 3006630150-2024-00771) where electrocautery may have been used.The patient underwent another revision procedure to replace the ipg and did well postoperatively.

Manufacturer Narrative

Analysis of the returned ipg revealed it would not charge despite multiple attempts, and communication could not be established with a known working remote control (rc) or clinician programmer (cp).As such, data logs could not be retrieved and analyzed, and functional testing could not be performed.The ipg was then dissected, and internal electrical measurements revealed excessive sleep current and low resistance of a node where high resistance was expected.This finding confirms that the application-specific integrated circuit (asic) chip was damaged.This damage is caused by the ipg being exposed to electrocautery during the reported revision procedure.

Event Description

It was reported that the deep brain stimulation (dbs) patient experienced rapid depletion of the implantable pulse generator (ipg) battery after undergoing a revision procedure (reported in mfr# 3006630150-2024-00771) where electrocautery may have been used.The patient underwent another revision procedure to replace the ipg and did well postoperatively.

• Brand Name: VERCISE GENUS
• Type of Device: STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN SYMPTOMS
• Manufacturer (Section D): BOSTON SCIENTIFIC NEUROMODULATION; 25155 rye canyon loop; valencia CA 91355
• Manufacturer (Section G): BOSTON SCIENTIFIC CORPORATION; cashel road; clonmel ; EI
• Manufacturer Contact: erik sherburne ; 25155 rye canyon loop; valencia, CA 91355 ; 7632920920
• MDR Report Key: 18728106
• MDR Text Key: 336508264
• Report Number: 3006630150-2024-00772
• Device Sequence Number: 1
• Product Code: NHL
• UDI-Device Identifier: 08714729985044
• UDI-Public: 08714729985044
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 05/06/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: DB-1216
• Device Catalogue Number: DB-1216
• Device Lot Number: 566946
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 02/07/2024
• Initial Date FDA Received: 02/16/2024
• Supplement Dates Manufacturer Received: 04/30/2024
• Supplement Dates FDA Received: 05/06/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/23/2023
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 79 YR
• Patient Sex: Male